Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
Study NCT ID:
NCT00920894
Status:
COMPLETED
Last Update Posted:
2009-11-05
First Post:
2009-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Plant Stanol Esters on Blood Lipids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C407042', 'term': 'plant stanol ester'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-04', 'studyFirstSubmitDate': '2009-06-12', 'studyFirstSubmitQcDate': '2009-06-12', 'lastUpdatePostDateStruct': {'date': '2009-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plasma lipids', 'timeFrame': '10 weeks'}], 'secondaryOutcomes': [{'measure': 'plasma lipoprotein lipids non-cholesterol sterols', 'timeFrame': '10 weeks'}]}, 'conditionsModule': {'conditions': ['Elevated Blood Lipids']}, 'descriptionModule': {'briefSummary': 'This study aims to measure the effect of plant stanol esters on serum total and lipoproteins lipids, non-cholesterol sterols and apolipoproteins in subjects with elevated fasting blood lipid concentrations', 'detailedDescription': 'The link between high serum low-density lipoprotein (LDL) cholesterol and cardiovascular disease has long been recognized. Dietary plant stanol esters have been shown to effectively reduce serum levels of total and LDL cholesterol. Plant stanols decrease the absorption of both biliary and dietary cholesterol from the small intestine and thereby reduce serum LDL cholesterol levels.\n\nThis study aims to verify the effect of plant stanol esters on blood lipids. Subjects with elevated fasting blood lipid concentrations will be randomized to study groups. The groups consume yoghurt type minidrink containing plant stanol ester (2 g plant stanols per day) or similar minidrink without plant stanol esters. After 10 weeks study period serum total and lipoproteins lipids, non-cholesterol sterols and apolipoproteins will by analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elevated blood lipids\n* Body Mass Index \\< 35 kg/m2\n* Stable body weight\n\nExclusion Criteria:\n\n* Receiving medications or supplements other than stable statin therapy known to affect lipid metabolism\n* Severe obesity\n* Hyperglycemia\n* Severe diseases (inc. diabetes, unstable CVD, malignant disease, inflammatory disease, gastrointestinal disease)\n* Hepatic, kidney or thyroid disease or disorder\n* Pregnancy or breast feeding\n* Severe intolerance or allergy to any ingredient of test product'}, 'identificationModule': {'nctId': 'NCT00920894', 'briefTitle': 'Effect of Plant Stanol Esters on Blood Lipids', 'organization': {'class': 'OTHER', 'fullName': 'Clinical Life Sciences Ltd.'}, 'officialTitle': 'The Effect of Plant Stanol Esters on Serum Total and Lipoproteins Lipids, Non-cholesterol Sterols and Apolipoproteins in Subjects With Elevated Blood Lipid Concentration', 'orgStudyIdInfo': {'id': 'Kainuu PlantStanol Ester Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'yoghurt type minidrink containing plant stanol ester', 'interventionNames': ['Dietary Supplement: plant stanol ester']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'yoghurt type minidrink without plant stanol ester', 'interventionNames': ['Dietary Supplement: plant stanol ester']}], 'interventions': [{'name': 'plant stanol ester', 'type': 'DIETARY_SUPPLEMENT', 'description': 'the effect of plant stanol esters on plasma lipids', 'armGroupLabels': ['yoghurt type minidrink containing plant stanol ester', 'yoghurt type minidrink without plant stanol ester']}]}, 'contactsLocationsModule': {'locations': [{'zip': '88610', 'city': 'Vuokatti', 'country': 'Finland', 'facility': 'Clinical Life Sciences Ltd', 'geoPoint': {'lat': 64.14466, 'lon': 28.28196}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinical Life Sciences Ltd.', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Päivi Cheney, MD', 'oldOrganization': 'Clinical Life Sciences Ltd'}}}}